Posts Tagged ‘drug company’

Grassley Wants Website Disclosing Conflicts of Interest—Letter Cites Harvard Psychiatrists Failure To Report Nearly $1 Million

Friday, August 5th, 2011

 In a letter to OMB [ Office of Management and Budget]  Sen. Chuck Grassley warned the administration not to back off from a proposed rule that would create a website to disclose medical researchers’ conflicts of interest. “I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers.” Grassley said he’s worked tirelessly “to shine light on these relationships, including with the help of Sen. Kohl in securing the passage of the Physician Payment Sunshine Act of 2009.” Read the letter here: http://1.usa.gov/r0OLYG

 

The Honorable Jacob J. Lew
Director
Office of Management and Budget
Eisenhower Executive Office Building
1650 Pennsylvania Avenue, NW
Washington, DC 20503

Dear Director Lew:
I write to you today regarding public disclosure of financial relationships between physicians and the drug, device and biologic industries. For the past three years I have worked to shine light on these relationships, including with the help of Senator Kohl in securing the passage of the Physician Payment Sunshine Act of 2009 (PPSA).

Before the passage of PPSA, in summer of 2008, I began releasing the results of my oversight work that demonstrated that universities are not and have not managed their professors’ financial conflicts of interest and that change is needed at the National Institutes of Health (NIH). Specifically, I found:

The Chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company’s drugs with an NIH grant. The Health and Human Services Office of the Inspector General (HHS OIG) is now investigating the matter.

The Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. He was later removed from the grant.

Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard released a report on the matter, and a briefing has been scheduled with my office.
I am concerned about recent reports that the Office of Management and Budget (OMB) may be attempting to weaken conflicts of interest rules proposed in May 2010 by the Department of Health and Human Services (HHS).

According to an article in Nature, OMB has removed the requirement for a publicly available website that would publish the conflicts of interests of researchers funded by taxpayers.1 I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers. Transparency is a backstop against such practices. I urge OMB to follow through and approve a rule that includes a publicly available website. OMB is the final arbiter of this decision. Any weakening of publicly available information requires careful scrutiny.

In order to understand why OMB appears to have concluded that weakening the HHS proposed conflict of interest rule is appropriate, I would appreciate your response to the following requests for documents:

1) Please provide all records relating to communications, including emails, with OMB staff regarding the Department of Health and Human Services’ proposed conflicts of interest rule from May 1, 2010, to the present.

2) Please provide all records, including calendar entries, relating to meetings with Administrator Cass Sunstein, OMB Office of Information and Regulatory Affairs, from May 1, 2010, to the present.

I request that OMB respond to my request by no later than August 25, 2011. Thank you for your attention to this important matter.

Sincerely,
Charles E. Grassley
Ranking Member
See the letter here: http://1.usa.gov/r0OLYG

 

« Return to news items


Share

In shift, feds target top execs for health fraud

Wednesday, June 1st, 2011

Business Week – May 31, 2011

By RICARDO ALONSO-ZALDIVAR

Federal investigators say they are starting to target individual executives in health care fraud cases previously aimed at impersonal corporations.

It’s raising the stakes for corporate honchos at drug companies, medical device manufacturers, nursing home chains and others who deal with Medicare and Medicaid.

Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a big check and promise not to break the rules again.

Now, on top of fines paid by a company, senior executives can face criminal misdemeanor charges even if they weren’t involved in the scheme but could have stopped it. And they can also be banned from doing business with federal programs, a career-ending consequence.

http://www.businessweek.com/ap/financialnews/D9NI94V01.htm

« Return to news items


Share

Psychiatric drug industry driven by wealth and stealth, not mental health

Tuesday, March 22nd, 2011

Natural News
By Monica Young
March 22, 2011

Drug company corporate websites tell us of their integrity and utmost commitment to people’s health and well-being. The American Psychiatric Association’s website begins with “Healthy Minds. Healthy Lives” and asserts the “highest ethical standards of professional conduct.” Yet a mountain of evidence points to an entirely different picture.

Most recently, thirty-eight state attorneys won a $68.5 million settlement with pharmaceutical titan AstraZeneca for unlawful marketing of antipsychotic Seroquel for unapproved use. These states also charged this company with failing to disclose the drug’s harmful side effects and concealing negative information about its safety and efficacy. “The company’s illegal practices put our most vulnerable populations at risk, including children and older patients with dementia and other debilitating diseases,” states Illinois Attorney General. U.S. sales of Seroquel brought in $5.3 billion for AstraZeneca last year.

Looking further, it’s evident that the pharmaceutical industry is fraught with fraud. For instance, the new generation of antipsychotics is the single biggest target of the False Claims Act. Every major drug company selling the drugs has either settled recent government cases for hundreds of millions of dollars or is under investigation for health care fraud.

Psychiatric drugs are notoriously high-priced. A year’s supply of one top antipsychotic is $7,000. A recent Biosocieties (scientific journal) article, entitled, “Demythologizing the high costs of pharmaceutical research,” exposes that drug companies widely exaggerate research costs to justify these prices. These companies typically cite a 2003 industry-funded study to claim a tag of over $1 billion to research and bring a drug to market. A new independent analysis indicates the figure is closer to $55 million.

Meanwhile drug company CEOs are some of the most excessively paid CEOs on Wall Street. Johnson & Johnson CEO’s publicly reported total compensation for 2009 (the last report available) was $25.6 million, including salary, bonus, stock options and other perks. This is three times the average for CEOs of S&P 500 companies and over 500 times the median American household income. His base salary was raised this year, despite an ongoing lawsuit, backed by the Department of Justice, accusing J&J of involvement in a kickback scheme to push their antipsychotic on elderly nursing home residents.

Drug manufactures spend billions yearly on marketing and advertising, far beyond what they spend on research. Billions go into direct to consumer advertising which drums a mantra to the masses: “ask your doctor if (___ medication) is right for you.” Billions are poured into marketing to doctors, including via drug sales reps – one of the most lucrative sales jobs in the U.S.

One ex-drug sales rep, Shahram Ahari, told a Senate Aging Committee that on top of a base salary for starting reps of $50,000, “there were four quarterly bonuses, an annual bonus, stock options, a car, 401k, great health benefits, and a $60,000 expense account.” He said his job involved “rewarding physicians with gifts and attention for their allegiance to your product and company despite what may be ethically appropriate.”

Another former drug sales rep and author of Confessions of an RX Drug Pusher, Gwen Olsen, says it’s all about the money. She described her hiring process. When asked why she wanted to become a pharmaceutical sales rep, she said she wanted to help people. The regional manager replied, “If that’s the case, you might want to join the Peace Corps…But if money is what motivates you, young lady, let me tell you how you can retire a millionaire.” Gwen reports that every manager she worked for said children are their biggest and most profitable expansion market.

Psychiatrists cash in big time as drug-pushers. The faster they shuffle people in and out for 15-minute medication management visits, the more they fill their deep pockets.

A recent New York Times article “Talk Therapy Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy,” gives an example of a practicing psychiatrist since 1972. He likens his office now to a bus station. In the old days of 45-minute talk sessions, “he knew his patients’ inner lives better than he knew his wife’s; now, he often cannot remember their names,” states the author. The doctor admits, “I had to train myself not to get too interested in their problems.”

And how much does the average psychiatrist make a year peddling drugs? $191,000.

Worldwide sales of antidepressants, stimulants, antianxiety and antipsychotic drugs exceed $82 billion a year. Yet for all the wealth this has brought these industries, are people truly getting better?

Psychiatric drugs have repeatedly proven to not only be extremely hazardous to one’s health but can be life-threatening and even fatal. Now the Archives of General Psychiatry has released scientific proof that antipsychotic drugs shrink brain tissue. (No wonder psychiatrists are called “shrinks”!)

Science journalist and author, Robert Whitaker, reports that long-term use of psychiatric medications is actually causing more mental illness – not less. He states “what you find with them when you look at long term outcomes, you see more people having chronic symptoms long term than you do in the unmedicated.”

Whitaker also points to disability statistics. Since the boom of psychiatric prescriptions began in 1987, adults on disability for mental illness more than tripled to 4 million. Amongst those on disability, the percentage of children has risen from about 5% in 1987 to over 50% today.

Of course the pill-pushers and their hordes of paid lobbyists, advocacy groups and spokesmen want us to believe that this means more mentally ill are finally getting the drug treatment they really need.

But who wants to believe a bunch of liars anyway?

« Return to news items


Share

California Official Accuses Bristol Bristol-Myers Squibb of Bribing Doctors to Prescribe Drugs

Friday, March 18th, 2011

Los Angeles Times, March 18, 2011

By Duke Helfand and Marc Lifsher

Pharmaceutical giant Bristol-Myers Squibb bribed thousands of California doctors and pharmacists to promote its drugs, using illegal kickbacks, lavish gifts and “happy hours” with the Los Angeles Lakers to expand its market share in the state, state officials said.

California Insurance Commissioner Dave Jones announced Friday that his office had joined a previously sealed whistleblower lawsuit against the company, calling it the largest health insurance fraud case ever pursued by a California state agency.

Two of the three whistleblowers in the case are former Lakers player Lucius Allen and his wife, Eve, who worked for the drug company as employees and provided access to the basketball team, whose players participated in “Lakers Dream Camps” set up by the drug company for doctors and their family members, the lawsuit said. The lawsuit was filed in 2007 but was sealed until the state joined the case recently.

New York-based Bristol-Myers Squibb issued a statement: “Bristol-Myers Squibb believes this lawsuit has no merit and the company will defend itself vigorously.”

The case is the latest major legal action against Bristol-Myers Squibb over allegations of fraud. The pharmaceutical giant paid $515 million in 2007 to settle allegations by the federal government and other states that it used a kickback scheme to defraud the Medicare and Medicaid insurance programs, officials said.

The California lawsuit alleges that Bristol-Myers Squibb targeted the private insurance industry, making thousands of payments to “high prescribing doctors” who wrote prescriptions for its well-known drugs, including Plavix, Abilify and Pravachol.

Jones said that insurance companies in California had spent more than $3.5 billion to cover the costs of the drugs Bristol-Myers Squibb sought to promote through its kickback scheme.

“We need to be sure that doctors are prescribing drugs because those drugs are best for their patients and not because a pharmaceutical company provided doctors with trips and kickbacks,” Jones said. “These illegal practices drive up the cost of health insurance for millions of Californians.”

http://www.latimes.com/business/la-fi-drug-kickbacks-20110319,0,5610786.story

« Return to news items


Share

Billion Dollar Drug Company Law Firm Restructures Connecticut Welfare System

Thursday, March 10th, 2011

By Bob Fiddaman and Shelia Matthews
March 10, 2011

For some time now, Sheila Matthews has been suspicious about her home state of Connecticut’s treatment of its most vulnerable children. As a mother of two children and co-founder of Ablechild, her instincts led her to scrutinize the dubious relationships among Connecticut’s Department of Children and Family Services [DCF], the pharmaceutical industry and a billion dollar law firm who has defended the likes of Pfizer Inc and Merck & Co., among others.

Sheila’s investigation has led her on a journey that links a non-profit children’s advocacy group, with assets over $15 million [2009] with nationally-renowned mass tort and class action defense law firms, to the Connecticut DCF – an $865 million bureaucracy, as described by the Connecticut Mirror.

The Connecticut DCF serves approximately 36,000 children and 16,000 families across its four Mandate Areas:

1. Child welfare;
2. Children’s behavioral health;
3. Juvenile Services; and
4. Prevention.

Sheila’s Ablechild has been questioning the Connecticut DCF since 2003, when Ablechild demanded that the Connecticut DCF immediately ban the use of the antidepressant Paxil in its treatment of mental disorders after multiple studies confirmed Paxil increased the risk of suicide in children and adolescents. This was more than a year prior to America’s Food & Drug Association (FDA) announcement that all antidepressants, including Paxil, should bear a black box warning regarding this suicide risk. Ablechild was disturbed that children in state custody were being prescribed this dangerous psychotropic medication. Ablechild’s public pressure paid off, and the Connecticut DCF deemed Paxil unsafe for children and adolescents, and according to the DCF drug approval list, Paxil has not been approved for use in over eight (8) years.

In August 2003, less than one month later, Ablechild reported that the commissioner of the Connecticut DCF held a ‘behind closed doors‘ meeting with Glaxo officials. This meeting was reported by the Associated Press, who wrote:

The maker of the anti-depressant Paxil plans to meet this week with Connecticut officials, weeks after the State stopped using the drug to treat young people in its care.

GlaxoSmithKline, a British pharmaceutical company, is sending its regional medical director and a medical team to meet with officials from the Department of Children and Families. [Source]

Despite repeated requests from Ablechild, the Connecticut DCF refused to inform the public what was discussed at this secret meeting.

Eight years later, Sheila and Ablechild continue to raise concerns and investigate potential wrongdoings and conflicts within the Connecticut DCF. Last month, in February 2011, Sheila attended a meeting sponsored by the Connecticut Behavioral Health Partnership [CBHP], where its medical director, Dr Steven Kant, presented the Husky Behavioral Pharmacy Data. The CBHP is a state vendor that provides mental health services to DCF children. These services are paid, in part, by the State-run insurance program, HUSKY. Incredibly the pharmacy data presentation showed that dangerous psychotropic drugs, like Paxil, are still being prescribed to thousands of children and adolescents. In fact, the Pharmacy Data presentation showed that the HUSKY program, financed by taxpayer dollars, paid drug companies over $60 million for psychotropic drugs for Connecticut’s children and adolescents in 2009 alone – many of which are not approved by the FDA for use in the pediatric population and all of which carry the most serious warning possible regarding the risk of suicide.

According to the pharmacy data presentation: [Which can be downloaded as a Powerpoint presentation HERE]

More than 50% of HUSKY Youth Behavioral med utilizers are on stimulants.
Close to 30% of HUSKY Youth Behavioral med utilizers are on antipsychotics.

The pharmacy data also revealed the following:

Most Frequently Used Behavioral Meds for DCF-Involved Youth

Medications for ADHD

Ritalin (10%)
Adderall (5%)
Vyvanse (4%)
Strattera (3%)

Atypical Antipsychotics

Abilify (11%)
Risperdol (10%)
Seroquel (8%)

Anti-anxiety

Hydroxyzine (2.5%)

Antidepressants

Prozac (4.5%)
Zoloft (4%)
Zyban (3%)
Desyrel (2.5%)
Celexa (2%)

Mood Stabilizers

Lithum (3%)
Depakote (3%)
Lamictal (2.5%)

Curiously, none of the above medications are on the Connecticut DCF list of approved/unapproved drugs listed in its DCF PMAC document.

With this in mind, Sheila Matthews contacted Dr Steven Kant and inquired as to whether any of the above drugs were approved by the Connecticut DCF for use in children.

Dr Kant replied:

… the answer to your question is not that straight forward.. . . Medications may be indicated by age and/or by specific treatment needs so it is not either a simply “yes” or “no”. Also, some medications may have the age indication but for a totally different condition, such as anti epileptic condition. . .Also FDA indications are static, they do not change over time though medical practice is constantly evolving…

Contradicting the very document that lists Connecticut’s approved and unapproved drugs, a “check-off” list that verifies the status of medications, Dr Kant replied, “I don’t think a “check off” for each medication would work in terms of verifying their status.”

With such an ambiguous response from Dr. Kant, we found the DCF Approved Medication List on the Internet. This particular version was revised in 2009.

It appears that the DCF has approved drugs in children that have not been approved for children by the FDA. In fact, the FDA has issued multiple advisories and alerts since 2004 about the increased risk of suicide in children, adolescents and young adults up to age 25 who are treated with psychotropic medications.

And while Fluoxetine (Prozac) is the only medication approved by the FDA for use in treating depression in children ages 8 and older, it still carries a black box warning regarding the risk of suicide.

In contrast, the DCF seems to be ignoring the conclusions of the FDA. Its list of approved medication in children and adolescents include every single antidepressant except paroxetine [Paxil] and venlafaxine [Effexor].

Forest Lab’s citalopram [Celexa] – APPROVED

Forest Lab’s escitalopram [Lexapro] – APPROVED

Solvay Pharmaceuticals’ fluvoxamine [Luvox] – APPROVED

Pfizer’s sertraline [Zoloft] – APPROVED

GlaxoSmithKline’s bupropion [Wellbutrin -also marketed as an anti-smoking cessation drug under the name of Zyban] – APPROVED [1]

Alarmingly, the DCF has produced a guide entitled, “MEDICATIONS USED FOR BEHAVIORAL & EMOTIONAL DISORDERS – A GUIDE FOR PARENTS, FOSTER PARENTS, FAMILIES, YOUTH, CAREGIVERS, GUARDIANS, AND SOCIAL WORKERS” where it writes, “Most of the side effects from the medications are mild and will lessen or go away after the first few weeks of treatment.” The guide also points out possible side effects of SSRI’s/SNRI’s:

SSRIs and SNRIs:

Headache
Nervousness
Nausea
Insomnia
Weight Loss

One of the most dangerous side effects of these medications, suicidal thoughts/ideation, doesn’t even make the 5 bullet-pointed list. The Guide does, however, add the following: “Watch for worsening of depression and thoughts about suicide.”

The DCF Approved Medication List writes:

“The DCF Approved Medication List is a list of psychotropic medications that has been carefully established by the Psychotropic Medication Advisory Committee, a group of DCF and community professionals.”

Sheila has since investigated other advocacy groups that were concerned about the off-label prescribing of psychiatric medications to youths in state custody. This is where she stumbled upon Children’s Rights, a non-profit charity based in New York City.

In 2005, Children’s Rights employed ten (10) attorneys and a staff of 31. It claims to use its expertise to change child welfare red tape and scrutinize failing systems. If the child welfare system fails to respond, Children’s Rights files a lawsuit. If successful, it enforces reform and then monitors its implementation.

In 1989, Children’s Rights had in fact filed a suit against William O’Neill and the Connecticut state Department of Children and Youth Services [DCYS].

The suit charged that an overworked and underfunded DCYS failed to provide services including abuse and neglect investigations, adoption, foster care, mental health care, caseloads and staffing. The case has been pending for over twenty (20) years, and while there have been numerous arguments that DCYS should be more inclusive or has failed to provide certain services, the issue of massive off-label prescription of psychotropic medications has never been brought to the court’s attention.

Children’s Rights is chaired by Alan C Myers, a partner at Skadden, Arps, Slate, Meagher and Flom, a billion dollar law firm which represents the pharmaceutical industry in mass torts and class actions. Myers is also co-head of the firm’s REIT Group [Real Estate Investment Trust].

Also, listed on the Children’s Rights website are individuals and law firms that have served as co-counsel on Children’s Rights’ legal campaigns to reform America’s failing child welfare systems, including:

Missouri - Shook Hardy & Bacon – Eli Lilly Co. and Forest Labs, defended the original Wesbeker Prozac trial in Kentucky and still defend Prozac, Celexa and Lexapro.

New JerseyDrinker Biddle & Reath – GlaxoSmithKline attorneys – defended Paxil as local counsel in Philadelphia cases.

OklahomaKaye Scholer LLP – provides work in Pharmaceutical Products Liability defense and employs an attorney who was former General Counsel of Pfizer, Inc.

A particular success for Skadden Arps occurred in 2010 when it secured a summary judgement ruling for Pfizer Inc. in a suit filed by two insurance companies who sought $200 million in damages for Pfizer’s predecessors alleged “off-label” marketing of its epilepsy drug, Neurontin.

Furthermore, in February 2011, Skadden Arps secured the dismissal of over 200 cases in a multi-district litigation pending against their client, Pfizer Inc. The plaintiffs had alleged injuries related to the use of Pfizer’s anti-epilepsy drug, Neurontin.

Neurontin, the generic version is called gabapentin, is prescribed by psychiatrists for a variety of “off-label” indications. It is often tried as an alternative treatment, when patients are unable to tolerate the side effect of more proven mood stabilizers such as lithium. [2]

Gabapentin has also been associated with an increased risk of suicidal acts or violent deaths.

This is a drug that has been known to cause behavioral problems, which include unstable emotions, hostility, aggression, hyperactivity or lack of concentration.

Children dependent on child welfare systems have rights and, according to its web page, Children’s Rights is dedicated to protecting them.

It should come as no surprise that the site fails to discuss the off-label prescription of non-approved psychotropic medications to children and adolescents, unless this falls under the ‘abuse and neglect’ category?

If Children’s Rights’ motive was to accomplish fixing the child welfare system then why hasn’t it investigated why thousands of children under state care are prescribed “off-label” psychiatric drugs? With a partner in a billion dollar pro-pharmaceutical law firm as its Chair, and supporters who also defend pharmaceutical products, is it safe to assume that its stance on the drugging of children is one that is being ignored?

Children’s Rights push to remove abused and neglected children into safety.

The basic question always comes down to trust. When power, money and a good cause is mixed, it is imperative to check motives. We would be less of a society if we didn’t check out all the facts. Abuse and neglect exist, always has and always will, but society is obligated to ensure those victims are not transformed into “good cause victims” and expensed out. There is no doubt we have a right to question the system and those who claim to promote change for the good of the children within it.

Children’s Rights Chairman, Alan C. Myers, Medical Director of Connecticut Behavioral Health Partnership, Steven Kant and the Connecticut Department of Children and Families may get their knickers in a twist with regard to an advocate of Ablechild and a blogger from Birmingham, UK questioning their motives but hey, what’s the downside of shinning a light on all these players, be they good or bad players?

Sheila’s concern is that Children’s Rights with its multi-million dollar budget and with the help of its billion dollar law firms, will continue to ignore the risks of these unapproved and dangerous medications, under the guise of helping our nation’s most vulnerable children. The question remains: how can the lawyers who defend psychotropic drugs also be the same lawyers who advocate for abused and neglected children to get into state welfare programs which place these children on the same drugs? The conflict is clear and obvious – and it poses an unmistakable danger to children who truly need our help.

[1] Bupropion [also known as Wellbutrin, Zyban] is a non-tricyclic antidepressant.
[2] Gabapentin

Bob Fiddaman is the author of the Seroxat Sufferers blog and the book, “The evidence, however, is clear… the Seroxat scandal.” Chipmunka Publishing.

Sheila Matthews is the co-founder of Ablechild and a mother of two children.

RETURN TO BLOGS PAGE


Share

Public ‘misled’ by drug trial claims

Wednesday, October 13th, 2010


Tablets
BBC NEWS
October 13, 2010
by Michelle Roberts

Doctors and patients are being misled about the effectiveness of some drugs because negative trial results are not published, experts have warned.

Writing in the British Medical Journal, they say that pharmaceutical companies should be forced to publish all data, not just positive findings.

The German team give the example of the antidepressant reboxetine, saying publications have failed to show the drug in a true light.

Pfizer maintains its drug is effective.    Reboxetine (Edronax), made by Pfizer, is used in many European countries, including the UK.

But its rejection by US drug regulators raised doubts about its effectiveness, and led some to hunt for missing data.  This is not the first time a large drug company

has come under fire about its published drug trial data.

Trial information

Pharmaceutical giant GlaxoSmithKline (GSK) was criticised for failing to raise the alarm on the risk of suicidal behaviour associated with its antidepressant Seroxat.

GSK rejected claims that it improperly withheld drug trial information.

But GSK has also been forced to defend itself over allegations about hiding negative data regarding another of its drugs, Avandia, which is used to treat diabetes.

Now researchers from The German Institute for Quality and Efficiency in Health Care say there is unpublished trial data for Pfizer’s antidepressant reboxetine that should be made public because it could change views about the drug.

Dr Beate Wieseler and colleagues carried out their own assessment of reboxetine, looking at the results of 13 trials, including eight previously unpublished trials from the manufacturer Pfizer.

They found the drug was no better than a placebo in terms of remission and response rates. And its benefit was inferior when compared with other similar antidepressants.

Furthermore, a higher rate of patients had side effects with reboxetine than with placebo. And more stopped taking the drug because of side effects compared with those taking a placebo or a different antidepressant.

Biased picture

The researchers said there has been a publication bias and this had overestimated the benefit of reboxetine and underestimated potential harm. And, they said, it was a widespread problem that applied to many of the drugs in use today.

“Our findings underline the urgent need for mandatory publication of trial data,” they say in the BMJ.

They warn that the lack of all information means policy makers are unable to make informed decisions.

Read the rest of this article here:  http://www.bbc.co.uk/news/health-11521873

« Return to news items


Share

Pharmaceutical Industry and Psychiatry—Conjoined Twins Joined at the Wallet, by former Pharma rep turned whistleblower

Friday, July 30th, 2010

OpEdNews
By K. L. Carlson
July 30, 2010

“Unlimited spending! Schedule all the programs you can.” That was the management directive announced at the regional business meeting I attended when I first became a pharmaceutical rep. When I heard the announcement I felt like I was on an Enron train that was roaring down the tracks, and the company expected everyone to be on board. The company was giving its sales force unlimited funds to hire physicians as paid speakers, sometimes to influence other physicians to prescribe the company’s drugs, at other times to simply financially reward physicians who wrote high volumes of prescriptions every month for the company’s drugs.

Former Merck regional sales manager, Gene Carbona, told the New York Times that the only thing the company considered when selecting physicians to provide presentations was “the volume or potential volume of prescribing that the doctor could do.” This is true of all pharmaceutical companies. According to The Wall Street Journal (August 31, 2009), Eli Lilly alone paid physicians $22 million dollars in just the first quarter of 2009.

The higher a physician is on the influential ladder, the greater the financial rewards to be reaped. Pharmaceutical companies pay influential leaders who can sway public opinion and influence research. And the area of medicine receiving the greatest amount of pharmaceutical money is psychiatry. The American Psychiatric Association (APA) is the most drug industry financially supported medical association. In July 2008, Senator Charles Grassley’s demands that the APA provide an accounting of its finances revealed that in 2006 the pharmaceutical industry accounted for about 30 percent of the APA’s financing; more than $20 million dollars.

Read entire article here:  http://www.opednews.com/articles/Pharmaceutical-Industry-an-by-K-L-Carlson-100727-454.html

« Return to news items


Share

BNET: ‘The Dog Ate AstraZeneca’s Homework! Evidence on Misleading Drug Ad Disappears From Company’s Files’

Wednesday, July 7th, 2010

BNET
By Jim Edwards
July 7, 2010

AstraZeneca (AZN) says it has lost a crucial internal document that would explain how an ad for its antipsychotic Seroquel misleadingly claimed there was “no weight gain” with the drug and described its “favorable weight profile.” But the company admits it kept the six-year-old envelope that once allegedly contained the ad’s approval certificate, according to a ruling by the U.K.’s Prescription Medicines Code of Practice Authority.

The drug industry watchdog also alleges AZ’s Seroquel management team “pressured and manipulated” executives around them in order to make sure negative data on Seroquel was buried. The PMCPA ruled that AZ had breached its code of practice, which requires companies to operate in “a professional, ethical and transparent” manner.

If there’s a lesson here for managers, it’s this: Simply winning the legal war isn’t good enough. Consumers — and your own employees, as the Seroquel case shows — expect companies to go above and beyond. (AZ has mostly won the litigation filed against it which alleges the company failed to warn patients that Seroquel causes weight gain and diabetes. It settled with the Department of Justice for $520 million.)

Many of the allegations in the PMCPA case are familiar, but what’s new is the source: One of the complainants was an unnamed male former AZ executive, employed at the company from 1992 to 2001, who from 1995 to 2000 was responsible for the medical aspects of the U.K. launch and subsequent marketing of Seroquel.*

In terms of the ad, the BBC reported in January that AZ had published a misleading ad in the British Journal of Psychiatry in April 2004. The PMCPA asked AZ to produce all the documentation behind the ad. Here’s its characterization of AZ’s response:

… for a product that had been marketed for more than 12 years in the UK, the company did not believe that it could reasonably investigate and respond to such a broad request in relation to specific clauses of the code.

The Code requires companies keep relevant documents for three years, AZ argued, and the ad itself was at least five years old, thus, “AstraZeneca had been unable to produce the certificate approving the advertisement from its archive.” But:

The Appeal Board noted from the AstraZeneca representatives at the appeal that although the job bag for the advertisement at issue still existed, it did not contain the relevant certificate.

How unfortunate!

More seriously, the PMCPA appeared to take seriously the ex-employee’s allegation that AZ buried or manipulated data on Seroquel long after the company became aware of weight-gain effects on its patients. The executive alleged that in 1997 he was told by a colleague…

Read entire article here:  http://industry.bnet.com/pharma/10008835/the-dog-ate-astrazenecas-homework-evidence-on-misleading-drug-ad-dissappears-from-companys-files/

« Return to news items


Share

AstraZeneca Denied Antipsychotic Drug’s Link to Diabetes for Years After Admitting Link to Japanese Physicians

Thursday, June 17th, 2010

Natural News
By David Gutierrez
June 17, 2010

Drug giant AstraZeneca attempted to obscure the connection between one of its blockbuster drugs and diabetes risk for years after it knew of the problem, according to documents recently unsealed as part of lawsuits against the company.

More than 15,000 patients have sought damages from the company, alleging that they were harmed by side effects from its atypical antipsychotic Seroquel. According to the plaintiffs, AstraZeneca deliberately hid information linking the drug to an increased risk of weight gain and diabetes. The lawsuits have been consolidated into a single case for the purpose of pre-trial proceedings.

The recently unsealed documents include notes from a meeting between salesperson Nancy White and a doctor in July 2006, during which the doctor said that his patients were expressing concern about Seroquel’s links to diabetes. White reported telling the doctor that “there has been no causative effect” proven between the drug and the disease.

Yet in November 2002, AstraZeneca had issued a warning to doctors in Japan that due to dozens of reports linking Seroquel to diabetes, “causality with the drug could not be ruled out.” The company cautioned doctors not to prescribe the drugs to diabetics and to encourage all Seroquel patients to monitor their blood sugar. Just over a year later, the company issued a similar warning to doctors in the United States.

Read entire article:  http://www.naturalnews.com/029012_AstraZeneca_diabetes_drug.html

« Return to news items


Share

DSM Panel Members Still Getting Pharma Funds

Friday, May 21st, 2010

Despite promises to cut back on Pharma funds, 56% of DSM V panel members have reported industry ties— Zero improvement over the percent of DSM-IV members.


By CCHR International
May 21, 2010

Due to Senate investigations into the American Psychiatric Association, psychiatrists have promised to cut back on their conflicts of interest (pharma funds), but of the current DSM task force members, those who will be deciding on the holy grail of psychiatric disorders (DSM) and what constitutes a “mental illness” are still heavily funded by Pharma. In fact, there is no improvement over cutting down the number of panel members who are getting paid by industry over the last DSM revision in 1994. It was 56% then and its 56% now. So much for psychiatry’s promises…

Former APA president Nada Stotland stated: “We are in the midst of a revolution caused by public and legislative concern about the influence of the for-profit sector….” [Emphasis added] Part of that public pressure for the APA to disclose its conflicts of interest with pharmaceutical companies was driven by Lisa Cosgrove Ph.D. et al’s study of DSM-IV and DSM-IV-TR committee members, which found that of the 170 members, 56% had one or more financial associations with companies in the pharmaceutical industry.  Pharma’s psychotropic drug profits have soared commensurately with the increased numbers of disorders voted into the DSM.

  • Of the 137 DSM-V panel members who have posted disclosure statements, 56% have reported industry ties—no improvement over the percent of DSM-IV members.
  • Writing in Psychiatric Times (March 6, 2010), Cosgrove and Harold J. Bursztajn, MD, stated: “Although the APA recently announced that it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding of the 2 philanthropic arms of the APA—the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE).”
  • APF’s 15-member board of directors includes 4 high-level executives from pharmaceutical companies that either manufacture drugs recommended by APA (i.e.; in APA’s Clinical Practice Guidelines [CPG]) or have products in development targeted for mental disorders.
  • Other board members include 2 more with industry ties and a senior vice president at one of the largest public relations agencies in the world, whose clients include 6 drug companies.
  • APF’s corporate advisory council comprises pharmaceutical companies that contribute significant funding to APF and manufacture drugs recommended in the APA’s CPG; 6 of the companies give $40,000 “and above” per year.
  • APIRE, like APF, does not require disclosure of financial conflicts of interests, yet 9 of 16 of its board members have industry ties.
  • At least a quarter of the presenters at this year’s APA congress have significant pharmaceutical company ties.

The APA should sever all ties to pharmaceutical company interests. The US Senate Finance Committee has investigated at least a dozen APA psychiatrists over their undisclosed financial ties to drug companies, including:

Investigated - Alan Schatzberg, APA President: Owned $6 million equity in and as co-founder of drug developer Corcept Therapeutics while principle investigator in an NIH-funded, Stanford-based study of Corcept’s drug mifepristone. Schatzberg initiated the patent application on mifepristone to “treat psychotic depression” in 1997. In 2008, after months of Congressional scrutiny, Schatzberg stepped down from his position as principal investigator in the study.


Investigated – Joseph Biederman: Chief of the Program in Pediatric Psychopharmacology, Massachusetts General Hospital, he earned $1.6 million in consulting fees from drug makers between 2000 and 2007, most of which was not disclosed to Harvard University officials. In March 2009, court documents showed Biederman promised Johnson & Johnson in advance that his studies of their antipsychotic Risperidone would prove effective when used on preschool age children.


Investigated - Melissa DelBello: Research psychiatrist, University of Cincinnati failed to disclose all her Pharma earnings. In 2002, she was the lead author of a study that reported patients benefited from Seroquel by AstraZeneca, which paid her $180,000. She disclosed receiving $100,000 from the company between 2005 and 2007, but federal investigators discovered it was more than double that—$238,000.


Investigated - Frederick Goodwin: Former NIMH director, Goodwin earned at least $1.3 million between 2000 and 2007 for marketing lectures to physicians on behalf of drug makers, which he did not reveal to the producers of “The Infinite Mind” that he hosted on the National Public Radio during its 10-year run. NPR removed the program.


Investigated - Charles Nemeroff: Perhaps the most egregious case exposed was that of Dr. Nemeroff, chair of Emory University’s department of psychiatry and, along with Schatzberg, coeditor of the influential Textbook of Psychopharmacology. He received more than $960,000 from GSK, but reported to Emory $35,000.  He earned a further $2.8 million from various drug makers but failed to report at least $1.2 million. Nemeroff resigned his position at Emory in 2008.


Investigated - Martin Keller: Professor of Psychiatry at Brown University. His (and others’) Study 329 (ghostwritten by a GSK rep.) on Paxil use in children allegedly misrepresented data and suppressed information linking Paxil to suicidal tendencies. Keller didn’t disclose the full extent of his financial ties with companies to medical journals that published his research. In another matter, following a criminal investigation, Brown University returned $300,170 to the state of Massachusetts for research Keller’s department never performed. Keller stepped down as chair of psychiatry at Brown.


Investigated - Augustus John Rush: Former Vice-Chairman of the Dept. of Clinical Sciences at the University of Texas Southwestern Medical Center. He reported only $3,000 of the nearly $18,000 that Eli Lilly paid him in 2001.  Between 2000 and 2007, he failed to report another $12,000 from various drug companies.


Investigated - Karen Wagner: Professor, University of Texas Medical Branch failed to disclose more than $160,000 in payments from GSK, reporting only $18,000. Wagner worked on NIH-funded studies on the use of Paxil to treat teen depression and was a co-researcher on Study 329 (see Keller), for which she was paid more than $18,000. In 2002, Eli Lily paid her over $11,000, which was not disclosed.


Investigated – Thomas Spencer: Assistant Director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Associate Professor of Psychiatry, Harvard Medical School, reportedly failed to disclose at least $1 million in earnings from drug companies between 2000 and 2007.


Investigated - Timothy Wilens: Associate Professor of Psychiatry at Harvard Medical School allegedly failed to report he had earned at least $1.6 million from drug makers.


RETURN TO BLOGS PAGE


Share